Could a single iron infusion help heart failure patients feel better?
NCT ID NCT07643818
First seen Jun 27, 2026 · Last updated Aug 25, 2026 · Updated 4 times
Summary
This study tests whether a single intravenous dose of iron (ferric derisomaltose) can improve symptoms, exercise ability, and quality of life in 150 adults with a type of heart failure called HFpEF who also have iron deficiency. Participants will receive either the iron infusion or a placebo and be followed for 12 weeks. The main goal is to see if they can walk farther in six minutes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ferric derisomaltose (Monofer) given as a single intravenous infusion
- What this could lead to
- If it works, this could provide a simple treatment to improve daily life and physical ability for people with a common type of heart failure.
- What could go wrong
- This is a small, early-phase trial (150 people) that hasn't started yet. It may not show clear benefit, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥18 years. * Willing and able to provide written informed consent. * Clinical diagnosis of heart failure with ejection fraction ≥40%. * New York Heart Association (NYHA) class II or III symptoms at the time of randomisation. * Ambulatory for at least 7 days prior to randomisation. * Iron deficiency defined as transferrin saturation (TSAT) \<20% or serum iron ≤13umol/L * Haemoglobin ≤15.0 g/dL. * Baseline 6-minute walk distance \<450 metres. Exclusion Criteria: * Unable or unwilling to provide informed consent. * Prior documented left ventricular ejection fraction (LVEF) \<40%. * Clinical signs or symptoms of active infection, including fever \>38°C. * Intravenous iron therapy, erythropoietin therapy, or blood transfusion within the previous 3 months. * Concurrent immunosuppressive therapy. * Known iron overload syndrome or haemochromatosis, or first-degree relative with haemochromatosis. * Known hypersensitivity to ferric derisomaltose (Monofer) or other intravenous iron preparations. * Known bleeding anaemia or haemolytic anaemia. * Any condition precluding exercise testing, including decompensated heart failure, unstable angina, obstructive cardiomyopathy, severe uncorrected valvular disease, significant musculoskeletal disease, or uncontrolled bradyarrhythmias or tachyarrhythmias. * Probable alternative explanation for symptoms in the opinion of the investigator, including severe obesity, primary pulmonary hypertension, or chronic obstructive pulmonary disease (COPD). * Severe COPD defined as FEV1 \<50%, requirement for home oxygen therapy, or chronic oral steroid therapy. * Renal replacement therapy or estimated glomerular filtration rate (eGFR) \<15 mL/min/1.73m². * Uncontrolled atrial fibrillation with resting heart rate \>110 beats/minute. * Uncontrolled hypertension with blood pressure \>180/110 mmHg. * Concurrent therapy with an erythropoiesis-stimulating agent. * Known active malignancy. * Known HIV infection or active hepatitis infection. * Pregnancy. * Decompensated liver disease.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Jersey General Hospital
Saint Helier, Jersey
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Other studies related to the condition(s) this trial covers.
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- Can tiny heart vessel damage predict heart failure?
- Can a new pill ease the burden of heart failure with preserved pumping?
- Iron and folic acid: a simple pill that could ease anemia and heart symptoms?